Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01695161
Other study ID # MZ-MPS-2012-01
Secondary ID
Status Recruiting
Phase N/A
First received September 25, 2012
Last updated February 28, 2013
Start date September 2012

Study information

Verified date February 2013
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)

- Fabry patients with cornea verticillata > grade 1

- Age = 12 years

- Patient is able to comply with the study procedure

- Patient has consented to be in the trial

- Ability to fixate a target

Exclusion Criteria:

- History of corneal transplantation or refractive surgery

- Corneal pathologies other than MPS-associated corneal opacity

- Corneal, conjunctival or intraocular inflammation

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Germany Department of Ophthalmology, University Medical Center, Johannes Gutenberg- Mainz

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary agreement between ccIOP and GAT in MPS, Fabry and healthy controls Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls Sep 2013 (anticipated) No
See also
  Status Clinical Trial Phase
Recruiting NCT04893889 - Substudy (NCT04456582): Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Two-dimensional Shear Wave Elastography) in Patients With Amyloidosis and Fabry Disease. N/A
Completed NCT04455230 - A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190 Phase 1/Phase 2
Completed NCT01218659 - Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease Phase 3
Completed NCT00304512 - A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease Phase 2
Withdrawn NCT04189601 - Complement Activation in the Lysosomal Storage Disorders
Completed NCT03500094 - Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years) Phase 3
Withdrawn NCT04143958 - To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease Phase 4
Recruiting NCT02994303 - Podocyturia - Predictor of Renal Dysfunction in Fabry Nephropathy N/A
Completed NCT01947634 - Sleepiness and Sleep-disordered Breathing in Fabry Disease. A Prospective Cohort Study. N/A
Completed NCT01853852 - A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects Phase 1
Completed NCT00701415 - A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms Phase 3
Completed NCT00068107 - Dosing Study of Replagal in Patients With Fabry Disease Phase 2
Completed NCT01997489 - Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients. Phase 4
Recruiting NCT06007768 - Autoimmune and Inflammatory Response Biomarkers in Fabry Disease
Recruiting NCT05698901 - Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease
Active, not recruiting NCT03305250 - Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease N/A
Terminated NCT00526071 - Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study Phase 2
Active, not recruiting NCT03566017 - Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease Phase 3
Recruiting NCT06065605 - Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease
Recruiting NCT06052800 - Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan